USPTO Patents Application 10687850

(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)

(19) World Intellectual Property Organization

International Bureau

(43) International Publication Date
27 September 2001 (27.09.2001)

PCT

Willi

(10) International Publication Number

WO 01/71329 Al

(51) International Patent Classification 7 ; G01N 27/26,
33/48

(21) International Application Number: PCT/KR01/00120

(22) International Filing Date: 30 January 2001 (30.01.2001)

(25) Filing Language: Korean

(26) Publication Language: English

(30) Priority Data:
2000-14424

22 March 2000 (22.03.2000) KR

(71) Applicant (for all designated States except US): ALL
MEDICUS CO., LTD. [KR/KR]; Samsung Life In-
surance, Kwanyang-Dong Building, 1st Floor, 1459-2,
Kwanyang 2-Dong, Dongan-Gu, Anyang, Kyunggi-Do
431-062 (KR).

(72) Inventors; and

(75) Inventors/Applicants (for US only): RYU, Jun-Oh
[KR/KR]; 98-9 Jongam2-Dong, Sungbuk-Gu, Seoul

136-092 (KR). LEE, Jin-Woo [KR/KR]; 402
Syunghwa- mansion, 1468-1, Gwanyang2-Dong, Don-
gan-Gu, Anyang, Kyunggi-Do 431-062 (KR). CHOI,
In-Hwan I KR/KR]; 401-1403, Dal-vit Macul, Hwa-
jeong-Dong, Deokyang-Gu, Koyang, Kyunggi-Do
412-270 (KR).

(74) Agents: CHO, Heum-O et al.; HO & CHO International
Patent & Law Office, Seo-won Building, 4th Floor, 1699-1
Seocho-Dong, Seocho-Gu, Seoul 137-070 (KR).

(81) Designated States (national): AE, AG, AL, AM, AT, AU,
AZ, BA, BB, BG, BR, BY, BZ, CA, CH, CN, CR, CU, CZ,
DE, DK, DM, DZ, EE, ES, FT, GB, GD, GE, GH, GM, HR,
HU, ID, IL, IN, IS, JP, KE, KG, KP, KZ, LC, LK, LR, LS,
LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NO,
NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR,
TT, TZ, UA, UG, US, UZ, VN, YU, ZA, ZW.

(84) Designated States (regional): ARIPO patent (GH, GM,
KE, LS, MW, MZ, SD, SL, SZ, TZ, UG, ZW), Eurasian
patent (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European
patent (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE,

[Continued on next page]

(54) Title: ELECTROCHEMICAL BIOSENSOR READOUT METER

I/O

.24

microprocessor

26

display

27

""-^ (57) Abstract: An Electrochemical biosensor readout meter which can do selectively quantitative analysis of sample of living body

^ such as blood sugar, cholesterol and other elements in blood is disclosed. It is an object of this invention to provide electrochemical
biosensor readout meter which has no distortion in peak current and can be manufactured in a low cost In a preferred embodiment
of present invention, a voltage converting means (OP2) is set to convert peak current which occurs at 3rd voltage applying time (t3)

^ into voltage with no distortion and an amplifier (OP3) is set to make digital voltage signal at measuring time (t4) lower than reference

^ voltage of A/D converter.

WO 01/71329 Al f fllfl Iffllfll fl Illffl ilflf ffll I If Iff f IHf If III fflf I »f f I llll I WIB fill Ml Bll

IT, LU, MC, NL, PT, SE, TR), OAPI patent (BR BJ, CF
CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG).

Published:

— with international search report

For two-letter codes and other abbreviations, refer to the "Guid-
ance Notes on Codes and Abbreviations" appearing at the begin-
ning of each regular issue of the PCT Gazette.

WO 01/71329

PCT/KR01/00120

ELECTROCHEMICAL BIOSENSOR READOUT METER
TECHNICAL FIELD

5

The present invention relates to an electrochemical
biosensor readout meter which can operate quantitative
analysis on specific biomaterials such as blood sugar,
cholesterol and so forth.

10

BACKGROUND ART

Recently electrochemical biosensors are frequently
used in medical field to analyze biomaterials including

15 blood. Among those, enzyme-utilizing electrochemical
biosensors are used most generally in hospitals and
clinical labs because they are easy to apply, superior in
measurement sensitivity, and allow rapid acquisition of
test results. Enzyme analyzing method applied in

20 electrochemical biosensors can be largely divided into
chromophoric method which is a spectroscopic way and
electrode method, an electrochemical way. Generally, the
measuring time in chromophoric method takes longer than
electrode method, and difficult to analyze significant

25 biomaterials due to the measurement errors caused by the
turbidity of biomaterials. Therefore, an electrode method
is extensively applied in electrochemical biosensors
recently. According to the method, in an electrode system
established by screen printing, the quantitative

3 0 measurement of a material of interest can be achieved by
fixing a reagent onto the electrodes, introducing a
sample, and applying an electric potential across the
electrodes .

U. S. Pat. No. 5 , 437, 999, "Electrochemical Sensor",
35 discloses an electrochemical biosensor test strip with a
precisely defined electrode field applying technologies

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2

generally used in PCB industries adequately to an
electrochemical biosensor test strip. This
electrochemical biosensor test strip can operate analysis
very precisely with a small amount of samples.
5 Fig - 1 is a plan view of a conventional

electrochemical biosensor test strip, in Fig. l,n is a
recognition electrode, 12 a reference electrode, 13 a
working electrode and 14 a reaction portion on which a
reagent is fixed.

10 Fig - 2 ^ a circuit diagram of a conventional

electrochemical biosensor readout meter using the test
strip 10 shown in Pig. i, Fig. 3A is a waveform of the
working voltage applied to the working electrode 13 by
the working voltage generating circuit 21, and Fig. 3B is
15 a waveform of the electric current flowing in the working
electrode 13 depending on the introduction of sample.

Below, referring to Fig. 2 and Fig. 3 , the
operation of a conventional electrochemical biosensor
readout meter 20 will be described. When a test strip io
20 as shown in Fig. l is inserted into the readout meter 20,
the voltage of point A changes into 0V from SV. This
change of voltage is recognized by a microprocessor 26
serving as a controller, and the insertion of the test
strip can be detected. At this point of detecting the
25 insertion of the test strip (to) , the microprocessor 26
controls a working voltage generating circuit 21 to apply
a fixed voltage, ■ for example 3 00mV, to a working
electrode 13 .

When blood and the like is introduced to the
30 reaction part 14 (tl), a material to be analyzed from
blood reacts with a reagent, generating electric charges
And these electric charges form the electric current by
the voltage which has been applied to the working
electrode 13. The electric current increases depending on
3 5 the advance of reaction between the reagent and the
material to be analyzed as shown in Fig. 3B. When the

WO 01/71329

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current becomes a certain amount (ith) (t2) , the
microprocessor 26 controls the working voltage generating
circuit 21 not to apply any voltage to the working
electrode 13 . The reason for waiting until the current
5 becomes a certain amount (ith) , is to prevent
malfunctioning by noise etc.

Since the working voltage is substantially 0V, the
electric charges generated by the reaction between the
material to be analyzed and the reagent, cannot flow via

10 the working electrode 13, gathering around the working
electrode 13 . After the working voltage is substantially
0V, at the point t3 # the working voltage of 300mv is
applied to the working electrode 13. Here, the time from
t2 to t3 is generally called 'incubation time' . The

15 electric charges gathering around the working electrode
during incubation time, simultaneously come to flow via
the working electrode 13, when the working voltage of
3 00mv is applied to the working electrode at t3.
Therefore, as shown in Fig. 3B the peak electric

20 current (Ip) emerges at t3 .

Referring to the circuit diagram in Fig. 2, the
principle of measuring the concentration of a material to
be analyzed by measuring the current flowing in the
working electrode 13 is described as follows. The current

25 flowing in the working electrode 13 is converted into the
voltage by the resistance (Rl) which is in feedback- loop
of the output terminal and the (-) input terminal of the
operational amplifier. This converted voltage is changed
into a digital signal by the analogue -digital (A/D)

30 converter 23. The microprocessor 26 has in store the data
on the relations of the material to be analyzed from
sample to the current. The microprocessor 26 measures the
concentration of the material to be analyzed, by reading
the current flowing in the working electrode 13 at the

35 time of t4 at which the peak current (Ip) has passed to
some degree. The reason for measuring the concentration

WO 01/71329

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4

10

15

of the material to be analyzed at t4, is that the value
of peak current varies with the state of coupling the
reagent to the reference electrode and the working
electrode, although the concentration of the material to
be analyzed from sample is same.

As described above, so far there was no voltage
applied to the working electrode during the incubation
time, so that the peak current at t3 was very high.
Therefore, if the resistance Rl becomes high, the
distortion of signal appears nearby t3 at which the peak
current occurs corresponding to the limitation of the
operational amplifier 0P1, accordingly the current at t4
is also affected. Fig. 4 a is the current waveform in case
that the resistance Rl is so small that the current
flowing in the working electrode can sufficiently flow
nearby t3. And Fig. 4b is the current waveform in case
that the resistance Rl is so large that the current
flowing in the working electrode cannot sufficiently flow
nearby t3 . In this case, the value of peak current varies
with the state of coupling the reagent to the reference
electrode and the working electrode so that the current
measured at t4 varies with the test strip used
Accordingly, there was the problem of reproduction. Also
if the resistance Rl is decreased so as to let a large
25 peak current flow without distortion, the waste of
expenses is occurred since the voltage measured at t4 is
relatively much smaller than the voltage at t3 and every
bit of A/D converter 23 cannot be used.

Besides, a conventional biosensor readout meter
30 used only one operational amplifier 0P1 so as to convert
the current flowing in electrodes into the voltage as
shown in Fig. 2. For example, when the reference voltage
of the A/D is 3.7V, the value of the resistance Rl lOOkQ
and the ( + ) power supply voltage of the operational
35 amplifier 5V, the current range measurable at t4 is
0<i<37uA and the maximum value of peak current allowable

20

WO 01/71329

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5

in the operational amplifier is SOjiA. If the value of
peak current is to be raised, the maximum current range
measurable at the time of t4 becomes higher than 37|oA.
In case the conversion bit of the A/D converter 23 is
5 8bit, if the maximum range of current grows larger, the
resolution grows worse. Therefore, to gain the preferable
resolution the conversion bit should be raised. In such
a case, since an expensive A/D converter should be used
there was the problem of a rise in expenses.

10

DISCLOSURE OF THE INVENTION

An object of the present invention is to provide
an electrochemical biosensor readout meter which does not

15 cause the distortion of peak . current so that the
reproducibility is improved.

Also, another object of the present invention is
to provide an electrochemical biosensor readout meter
with high resolution at low expense.

20 To achieve the objects as described above, this

invention is characterized in a readout meter using the
electrochemical biosensor test strip provided with an
insulating substrate, a reference electrode and a working
electrode formed parallel in a lengthwise direction on

25 the insulating substrate, and a reagent which is fixed
over the reference electrode and the working electrode on
the insulating substrate, and generates electric charges
corresponding to the concentration of a specific material
to be analyzed by reacting to this material depending on

3 0 the insertion of sample, comprising:

a working voltage generating circuit applying a
working voltage to the working electrode; a voltage
converting device converting the electric current flowing
through the working electrode into voltage; an amplifier

3 5 outputting an analogue voltage signal, amplifying the
converted voltage from the voltage converting device; an

J

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30

35

A/D converter converting the analogue voltage signal from
the amplifier into a digital voltage signal; a controller
which operates the working voltage generating circuit to
apply a first voltage to the working electrode when the
5 test strip is inserted into the readout meter (to), to
apply a second voltage to the working electrode for a
fixed period of time after a certain time (t2J when the
sample is inserted (tl) , then(t3) operates the working
voltage generating circuit to apply a third voltage to
10 the working electrode, and measures the concentration of
the material to be analyzed by reading the digital
voltage signal from the A/D converter after a certain
time(t4) from the applying point of the third
voltage(t3); wherein the voltage converting device is set
15 to convert the peak in the current generated at the
applying point of the third voltage (t3) into the
corresponding voltage without distortion, and the
amplifier is set to make the digital voltage signal at
the measuring point (t4) become below the reference
2 0 voltage of the A/D converter.

Also, this invention is characterized in a readout
meter using the electrochemical biosensor test strip
provided with an insulating substrate, a reference
electrode and a working electrode formed parallel in a
IS lengthwise direction on the insulating substrate, and a
reagent which is fixed over the reference electrode and
the working electrode on the insulating substrate, and
generates electric charges corresponding to the
concentration of a specific material to be analyzed by
reactmg to this material depending on the insertion of
sample, comprising;

a working voltage generating circuit applying a
working voltage to the working electrode; a voltage
converting device converting the electric current flowing
through the working electrode into a analogue voltage
signal; an A/D converter converting the analogue voltage

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7

signal from the voltage converting device into a digital
voltage signal; a controller which operates the working
voltage generating circuit to apply a first voltage to
the working electrode when the test strip is inserted
5 into the readout meter (to) , to apply a second voltage to
the working electrode for a fixed period of time after a
certain time(t2) when the sample is inserted (tl) ,
then(t3) operates the working voltage generating circuit
to apply a third voltage to the working electrode, and

10 measures the concentration of the material to be analyzed
by reading the digital signal from the A/D converter
after a certain time(t4) from the applying point of the
third voltage(t3); wherein the second voltage is not
substantially 0V and smaller than the first voltage.

15 In accordance with the present invention, it is

possible to provide an electrochemical biosensor readout

meter with high reproducibility by preventing the

i

distortion of the peak current. Also, it is possible to
provide an electrochemical biosensor readout meter with
20 high resolution at low expense.

BRIEF DESCRIPTION OF THE INVENTION

Fig. 1 is a plan view of a conventional
25 electrochemical biosensor test strip.

Fig. 2 is a circuit diagram of a conventional
electrochemical biosensor readout meter.

Fig. 3A shows a waveform of a conventional working
voltage, and Fig. 3B is a waveform illustrating the
30 current flowing through the working electrode.

Fig. 4 shows a waveform of the current flowing
through the working electrode, illustrated as the peak
current distorted.

Fig. 5 is a circuit diagram of an electrochemical
35 biosensor readout meter in accordance with an embodiment
of the present invention.

WO 01/71329

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8

Fig. 6A shows the waveform of the working voltage
according to the present invention, Fig. 6B is a waveform
illustrating the current flowing through the working
electrode

5

BEST MODES FOR CARRYING OUT THE INVENTION

Hereinafter, an embodiment of the present invention
will be described in detail with reference to the

0 accompanying drawings.

Fig. 5 shows a circuit diagram of the
electrochemical biosensor readout meter according to this
invention. Like reference numerals are used for like
components shown in Fig. 2 . Compared with the

5 conventional electrochemical biosensor readout meter
shown in Fig. 2, the present invention is different in
that the operational amplifier converting the current
flowing through the working electrode 13 into the voltage
and inputting this voltage to the A/D converter 23, is'

> composed of two stages while the conventional one is
composed of one stage.

Fig. 6A is a waveform of the working voltage
applied to the working electrode, and Fig. 6B shows a
waveform of the current flowing through the working
electrode in accordance with this invention.

Referring to Fig. 5 and Fig. 6 , the operation will
be described in detail. when the test strip io is
inserted into the readout meter 50 (tO) , the value of
point A is turned into 0V from 5V by the recognition
electrode 11, and the microprocessor 26 recognizes by the
change of voltage whether the test strip io is inserted
At this time, as shown in Fig. 6A , the microprocessor 26
operates the voltage generating circuit 4 3 to apply 3 0 0mV
to the working electrode 13. And waits until the blood
is inserted into the reaction part 14 of the test strip
10. When the blood is inserted into the reaction part 14

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PCT/KR01/0012O

9

of the test strip 10 (tl) , as shown in Pig. 6A, the
microprocessor 26 waits till the current flowing in the
test strip 10 becomes more than a fixed value (t2) ,.
distinguishes the insertion of the blood, and operates
5 the working voltage generating circuit 21 to apply 74mV,
not substantially OV, as a working voltage to the working
electrode 13 of the test strip 10.

In Fig. 5, the first operational amplifier OP2 is
to determine the peak current, and the second operational
10 amplifier OP3 is to determine the maximum current which
the A/D 23 can measure. When the peak current is called
Ip and the voltage applied to the ( + ) power supply
terminal of the operational amplifier 0P2 is + 5V, , Ip is
determined as Ip=5/R2. In case R2 is 10KQ, Ip is SOO^A.
15 When R5 is set to equal R8 and R6 is R7, the
amplification factor of the second operational amplifier
OP3 is R6/R8. Therefore, the amplification factor of. the
current which the A/D converter 23 reads, equals R2R6/R8.
Accordingly, when R2 is set to 10kQ, R6 470kQ, and R8
20 51kQ, the maximum current which can be read at t4 is
3.7/(10k*470K/51K) , that is 40.1fiA.

If the peak current (Ip) becomes larger, it is
practicable to decrease R2 and control the ratio of R6/R8,
so that the peak current (Ip) and the maximum current read
25 at t4 can be independently controlled. Therefore, as
shown in Fig. 6B, the current waveform of which the peak
current is distortionless, can be achieved.

In the present invention, as shown in Fig. 6A, the
working voltage of 74mV was applied, not OV, for the
30 incubation time. Thereby, the current generated by the
chemical reactions is exhausted little by little for the
incubation time so that the peak current (IP3) of Fig. SB
becomes smaller than the peak current (IPO) of the time
when 0V is applied. Therefore, in case of measuring the
35 same concentration, the peak current is constant.
Accordingly, the reproduction can be better as the

WO 01/71329

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10

measurement is repeated because the value measured at t4
becomes constant .

WO 01/71329

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11

CLAIMS

1. A readout meter using the electrochemical
biosensor test strip provided with an insulating
5 substrate, a reference electrode and a working electrode
formed parallel in a lengthwise direction on the
insulating substrate, and a reagent which is fixed over
the reference electrode and the working electrode on the
insulating substrate, and generates electric charges

10 corresponding to the concentration of a specific material
to be analyzed by reacting to this material depending on
the insertion of sample, comprising:

a working voltage generating circuit applying a
working voltage to the working electrode;

15 a voltage converting device converting the electric

current flowing through the working electrode into
voltage;

an amplifier outputting an analogue voltage signal,
amplifying the converted voltage from the voltage
20 converting device;

an A/D converter converting the analogue voltage
signal from the amplifier into a digital voltage signal;
and

a controller which operates the working voltage
25 generating circuit to apply a first voltage to the
working electrode when the test strip is inserted into
the readout meter (to), to apply a second voltage to the
working electrode for a fixed period of time after a
certain time(t2) when the sample is inserted (tl) ,
30 then(t3) operates the working voltage generating circuit
to apply a third voltage to the working electrode, and
measures the concentration of the material to be analyzed
by reading the digital voltage signal from the A/D
converter after a certain time(t4) from the applying
35 point of the third voltage (t3);

wherein the voltage converting device is set to

WO 01/71329

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12

convert the peak in the current generated at the applying
Point of the third voltage (t3) into a corresponding
voltage without distortion, and the amplifier is set to
make the digital voltage signal at the measuring time(t4)
5 become below the reference voltage of the A/D converter.

2. The electrochemical biosensor readout meter as
set forth in claim 1,

wherein the third voltage is the same as the first
voltage is.

10 3. The electrochemical biosensor readout meter as

set forth in claim 1 or claim 2,

wherein the second voltage is not substantially 0V
and less than the first voltage.

4. A readout meter using the electrochemical
15 biosensor test strip provided with an insulating
substrate, a reference electrode and a working electrode
formed parallel in a lengthwise direction on the
insulating substrate, and a reagent which is fixed over
the reference electrode and the working electrode on the
20 insulating substrate, and generates electric charges
corresponding to the concentration of a specific material
to be analy 2ed by reacting to this material depending on
the insertion of sample, comprising:

a working voltage generating circuit applying a
working voltage to the working electrode;

a voltage converting device converting the electric
current flowing through the working electrode into an
analogue voltage signal;

an A/D converter converting the analogue voltage
signal from the voltage converting device into a digital
voltage signal; and

25

30

a controller which operates the working voltage
generating circuit to apply a first voltage to the
working electrode when the test strip is inserted into
the readout meter (to) , to apply a second voltage to the
working electrode for a fixed period of time after a

WO 01/71329

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13

certain time(t2) when the sample is inserted (tl) ,
then(t3) operates the working voltage generating circuit
to apply a third voltage to the working electrode, and
measures the concentration of the material to be analyzed

5 by reading the digital signal from the A/D converter
after a certain time(t4) from the applying point of the
third voltage (t3) ;

wherein the second voltage is not substantially 0V,
and less than the first voltage.

0 5. The electrochemical biosensor readout meter as

set forth in claim 4,

wherein the third voltage is the same as the first
voltage is.

PCT/KR01/00120

1/6

FIG. 1

]

13

14

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3/6

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4/6

FIG. 4

b

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6/6

300mV

FIG. 6A

74mV -

FIG. 6B

T- t

INTERNATIONAL SEARCH REPORT Fhternational application No.

PCT/KR01/00I20

CLASSIFICATION OF SUBJECT MATTER '

IPC7 GOIN 27/26, COIN 33/48
According to International Patent Classification (IPC) or to both national classification and IPC

~S FIELDS SEARCHED ~

(vnnimun documentation searched (classification system followed by classification symbols) ;

IPC7 GOIN 27, 33, 27/26, 27/327, 33/48

uocumentation searched other man mimmun documentation to the extent that such documents are incl uded in the filcds searched
Korean Patents and applications for inventions since 1975
Korean Utility models and applications for Utility models since 1975

tlectronic data base consulted during the international search (name of data base and, where practicable, search trerms used)

C DOCUMENTS CONSIDERED TO BE RELEVANT

Category*

Citation of document, with indication, where appropriate, of the relevant passages

Relevant to claim No.

A

JP 1-15649 A (DAIKIN 1ND LTD.) 19 Jan. 1989
see the abstract

1-5

A

JP 2-6733 A (DAIKIN IND LTD.) 10 Jan. 1990
see the abstract

1-5

A

US 4,999.582 A (PARKS el al.) 12 Mar. 1991
see the whole document

1-5

A

JP 3-156358 A (DAIKIN IND LTD.) 4 Jul. 1991
see the abstract

1-5

A

US 5,858, 1 86 A (Glass, Robert S.) 12 Jan. 1999
see the whole document

1-5

| I Further documents are listed in the continuation of Box C

| j See patent family annex.

•A- h£™ ^ T'"* ?l d0 , Cumen,s j , T laeer document published .Her .he in.erua.Kmal filing da.e or priori* "
A document defin.ng Ike general state of the «t wh«:h .s no. considered date Qnd not in conflict whh the application but cited <o understand
... of pabular relevence the principle or theory unde,l,in 8 the invention

HUn toe ° r Pa,e '" °" ° r in,ema,i0nal " X " docum «" °' P**»l" relevcnce; the claimed invention eannol be
•i" °! l u »t- , . considered novel or cannot be considered to involve an inventive

d0C r em w L h ' ch m "y ,hrow doubls ° n f™"* cI »""ts) or which is stcp whe „ u, e docurnen , is takcn alone

cited to estabhsh the publication date of citation or other » Y " document of particular relevcnce; the claimed invention cannot be
spec.nl reason (us spect.cd) considered to involve an inventive step when the document is
" refemngto an oral disclosure, use, cxh.bi.ion or other combincd wilh one or more o.hcr such documen.s.such combination
nn „ . . . .. . , . being obvious to a person skilled in the art

1 document published prior to the international filing date but later document member of the same patent family
than the priority dale claimed

uaic oi tnc actual completion of the international search
21 MAY 2001 (21.05.2001)

Date ol mailing of the international search report
22 MAY 2001 (22.05.2001)

Name and mailing address ol the ISA/KR
Korean Intellectual Property Office

Government Complex-Daejeon. Dunsan-dong, Sco-gu. Daejeon
Metropolitan City 302-701. Republic of Korea

Facsimile No. 82-42-472-7140

l-orm PC 1 /ISA/210 (second sheet* CJi.lv ig<>R\

Authorized oilicer

KIM, Sang Hoc
Telephone No, 82-42-48 1 -5974